NDC 49771-002-01 - Mitosol
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 49771-002
- Requested NDC
- 49771-002-01
- Package NDCs from labels
- 49771-002-01, 49771-002-03
- Manufacturer
- Mobius Therapeutics LLC
- Effective date
- 2025-04-23
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Mitosol - Mobius Therapeutics LLC | Mobius Therapeutics LLC | 2025-04-23 | HUMAN PRESCRIPTION DRUG LABEL |
| National Council for Prescription Drug Programs indexing - billing unit | National Council for Prescription Drug Programs | 2012-07-24 | Indexing - Billing Unit |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49771-002-01 | Mitosol | 1 in 1 TRAY | KIT | 1 | 10 | |
| 49771-002-03 | Mitosol | 3 in 1 CARTON | KIT | 3 | 10 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49771-002-01 | EA - Each | 49771-002 | cb571edc-741e-43e9-8fbb-232ee4982cc7 | 1 | 2012-07-24 |
| 49771-002-03 | EA - Each | 49771-002 | 867c011f-739b-48b4-ac43-e71cd6e05864 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ISOPROPYL ALCOHOL | ACTIVE INGREDIENT | ND2M416302 | MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC] | 3 | |
| Mitomycin | ACTIVE INGREDIENT | 50SG953SK6 | MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC] | 3 | |
| ISOPROPYL ALCOHOL | ACTIVE MOIETY | ND2M416302 | MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC] | 3 | |
| Mitomycin | ACTIVE MOIETY | 50SG953SK6 | MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC] | 3 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC] | 3 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | MITOSOL (MITOMYCIN) KIT [MOBIUS THERAPEUTICS LLC] | 3 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sterile Water | WATER | Civica, Inc. | 3f49eedf-5bf5-4a95-b704-c956d860ca04 | 2023-04-07 | Warnings, Adverse reactions | 059QF0KO0R |
| Treprostinil | TREPROSTINIL | Sandoz Inc | 473297ca-a872-4052-a053-87dc8f0d3c13 | 2023-04-06 | Warnings, Adverse reactions | 059QF0KO0R |
| Mannitol | MANNITOL | Fresenius Kabi USA, LLC | c395e13d-6ea1-4104-8b37-669cfb982f04 | 2023-03-16 | Warnings, Adverse reactions | 3OWL53L36A |
| NOVOLOG | INSULIN ASPART | Novo Nordisk | 3a1e73a2-3009-40d0-876c-b4cb2be56fc5 | 2023-02-28 | Warnings, Adverse reactions | 059QF0KO0R |
| MITOMYCIN | MITOMYCIN | Fresenius Kabi USA, LLC | bc937e3d-7167-49a5-b6b1-004b0f89d8c4 | 2023-01-12 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Rehydrate | AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADEN | ParaDocs All Natural, Inc. | 648fab10-c46b-420f-a42c-6642009d83fb | 2023-01-10 | Warnings | 059QF0KO0R |
| MITOMYCIN | MITOMYCIN | Fresenius Kabi USA, LLC | 6a4fbc96-e35d-41c2-91fc-4b48220bdba2 | 2023-01-09 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| MITOMYCIN | MITOMYCIN | Gland Pharma Limited | 2528999b-9f09-4e64-89fc-1e3d69c2d0b6 | 2022-11-23 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | b45e9f1d-9c48-4b46-8541-d846b89540df | 2022-10-26 | Warnings, Adverse reactions | 059QF0KO0R |
| Eye wash | PURIFIED WATER | McKesson | bd089fde-24ba-4de5-e053-2995a90a39bb | 2022-10-18 | Warnings | 059QF0KO0R |
| Bach Original Flower Remedies Rock Water | WATER | Nelson Bach USA Limited | ea242559-1618-3354-e053-2a95a90a1a95 | 2022-10-03 | Warnings | 059QF0KO0R |
| Mitomycin | MITOMYCIN | Hikma Pharmaceuticals USA Inc. | fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8 | 2022-09-27 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Sterile Water | WATER | Medical Purchasing Solutions, LLC | e90b47e3-9636-b9ee-e053-2a95a90ad48c | 2022-09-19 | Warnings, Adverse reactions | 059QF0KO0R |
| MITOMYCIN | MITOMYCIN | Meitheal Pharmaceuticals Inc. | 9dd0e3f2-0938-4c57-8d09-040b5405b44f | 2022-09-08 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | f42ac50f-0ec5-4713-a4c8-99d972d90bed | 2022-06-22 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | Fresenius Kabi USA, LLC | e71c6c83-d518-496c-b2ab-efd5987e4783 | 2022-06-09 | Warnings, Adverse reactions | 059QF0KO0R |
| Sterile Water | WATER | American Regent, Inc. | 78b35864-4bbc-4759-a5c1-7e4f25e22932 | 2022-01-31 | Boxed warning | 059QF0KO0R |
| Sterile Diluent for Treprostinil | WATER | Dr.Reddy's Laboratories Inc., | 33050ee2-519b-1f0b-d4df-9e14dd329c57 | 2021-12-23 | Warnings, Adverse reactions | 059QF0KO0R |
| MITOMYCIN | MITOMYCIN | Gland Pharma Limited | 650d3024-b9a9-4018-8115-0951acfe3145 | 2021-10-22 | Boxed warning, Warnings, Adverse reactions | 50SG953SK6 |
| Sterile Water | STERILE WATER | B. Braun Medical Inc. | d99f9133-e4d0-4dee-b611-dbc3f918b547 | 2021-08-09 | Warnings, Adverse reactions | 059QF0KO0R |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.